Recent Updates
Recently added Catalysts

Hydromorphone

Phase 1

Pain | Small molecule | Pain |Masimo Corporation|Last Updated: Jan 3, 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Hydromorphone · 1 trial · 1 indication

Early Phase 1 1
NCT01866254Use of Intrathecal Hydromorphone in Elective Cesarean DeliveriesPain
COMPLETED45 Analytics
EARLY_PHASE1COMPLETED
Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
Pain
NCT0186625445
Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in Pain Scores
from Baseline to 24 Hours

Pain scores to be measured using the verbal response scale (VRS). The VRS pain score is measured on a scale of 0-10 with 0 representing absolutely no pain and 10 representing worst pain imaginable

Secondary Endpoints

Number of Participants with Adverse Events (AEs)
up to 24 Hours
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HydromorphoneEXPERIMENTAL100 mg, intrathecal administration
MorphineACTIVE_COMPARATOR200 mg, intrathecal administration

Interventions

NameTypeDescription
HydromorphoneDRUGInjection of 100 mcg hydromorphone into the intrathecal space
MorphineDRUGInjection of 200 mcg of intrathecal morphine
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Scheduled for elective Cesarean sections under spinal anesthesia or combined spinal anesthesia * ASA status of I-III * BMI \< 40 * Able to understand and sign informed consent Exclusion Criteria: * Severe pre-eclampsia * Conversion to general anesthetic * History of chronic ...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Hydromorphone

What is Hydromorphone used for?

Hydromorphone is a small molecule being developed for pain. It is being studied for use in elective cesarean deliveries, specifically as an intrathecal (spinal) treatment to manage pain in that setting. The drug is currently in early Phase 1 clinical development.

Who makes Hydromorphone?

Hydromorphone is being developed by Masimo Corporation, a company publicly traded under the ticker MASI. The drug is currently in early Phase 1 clinical development for pain, with one completed clinical trial.

What phase is Hydromorphone in?

Hydromorphone is in early Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One early Phase 1 trial has been completed, and the drug is not yet in later-stage clinical trials.

What clinical trials is Hydromorphone in?

Hydromorphone has one completed clinical trial, NCT01866254, titled 'Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries.' This early Phase 1 study enrolled 45 female participants aged 18 years and older in the United States and was active-controlled.

Is Hydromorphone the same as other pain medications?

Hydromorphone is a specific opioid analgesic used for pain management. It is not the same as other pain medications like morphine or fentanyl, though it belongs to the same class of drugs. Its development by Masimo Corporation focuses on intrathecal use for cesarean delivery pain.